Clinical Scientist & Liaison Manager (Hybrid in NYC)
Our client is seeking a highly skilled and motivated Clinical Scientist and Liaison Manager with extensive clinical science experience to join their dynamic clinical development team.
Company offers a very generous compensation & benefits package.
MUST HAVES:
- Strong Scientific Background: A solid scientific foundation, such as a PhD in molecular biology or oncology, is important for understanding and communicating complex clinical matters.
- Protocol Writing: Someone capable of taking ownership of clinical study protocols and drafting sections independently.
- KOL Experience: Relationships with Key Opinion Leaders (KOLs) are key for advancing clinical trials and medical strategies.
- FDA Requirements and Compliance: Experience in implementing FDA requirements, like diversity plans in study protocols, is important.
- Hands-on Study Execution: Candidates should be confident in taking on key responsibilities such as CRO selection, site meetings, and study protocol development.
- Analytical Skills: The role requires strong analytical skills, particularly in assessing clinical data and solving operational challenges.
THIS ROLE INVOLVES:
- Protocol development: Objectives, methodology, data collection methods, and analysis plans.
- Medical writing: Writing, reviewing, and updating the clinical trial protocol, informed consent documents, and case report forms (CRFs).
- Regulatory Submissions: Investigational New Drug (IND) applications, New Drug (NDA) applications, Clinical Trial (CTA) applications
- Data Management: Data Analysis reports, eCRF review, Quality Control
- Safety reports: Adverse event review, Pharmacovigilance Reports
- Communication: Preparing presentations, manuscripts, clinical study reports (CSR) and other scientific communications based on study results, KOL interaction
KEY RESPONSIBILITIES:
Scientific & Clinical Research Project & Content:
- Design, implement, and manage clinical research documents and studies to support product development and regulatory approval.
- Analyze and interpret and communicate scientific & clinical data, ensuring accuracy and scientific integrity.
- Ensure all clinical trial documentation complies with regulatory requirements, company policies, and ethical standards.
- Prepare and present clinical study reports, summaries, and publications for internal and external dissemination.
- Monitor and report study progress to relevant authorities and stakeholders.
Stakeholder Liaison:
- Serve as the main point of contact between the company, clinical sites, and external partners, including regulatory bodies and key opinion leaders (KOLs).
- Facilitate clear and consistent communication to address any inquiries, concerns, or updates related to clinical projects.
- Build and maintain strong relationships with clinical investigators, healthcare professionals, and other stakeholders.
R&D Strategy Support:
- Contribute to the development of clinical strategies and trial designs that align with company objectives.
- Provide scientific input and expertise in the preparation of regulatory submissions and presentations.
- Support in licensing projects, clinical and indication strategy assessment.
EXPERIENCE:
- A minimum of 5 years' experience in clinical research or pharmaceutical industry role with proven experience in clinical science, project management and liaison responsibilities.
EDUCATION: PhD in molecular biology or oncology is preferred.